Topic
drug approval
FDA Panel Endorses Unproven Peptides, Opening Door for Compounding Pharmacy Manufacturing
An FDA advisory panel voted 8-6 to recommend reclassifying three unproven peptides—BPC-157, KPV, and TB-500—allowing compounding pharmacies to produce them. A fourth peptide, MOTs-C, received a 7-5 vote in favor. The decision could reshape pharmaceutical manufacturing supply chains, as China and India are major suppliers of these peptides.
Human Genetic Evidence Found to Be Strongly Associated with Drug Approval in Observational Study of 26,278 Target-Disease Pairs
A new observational study analyzing 26,278 target-disease pairs from Open Targets and ChEMBL found that drug targets with human genetic evidence are 3.25 times more likely to receive approval. The enrichment replicated in post-2015 approvals. Feature ablation revealed that literature mining dominates predictive performance, but the classifier has limited practical value. The study catalogs 1,433 genetically supported Phase 1/2 pairs for hypothesis generation.